MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-85

Device Problems Failure to Calibrate (2440); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).The reported issue was identified by the livanova technician during routine maintenance.The technician was able to trace the reported issue to a faulty temperature probe and processor board.Both parts were replaced to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The replaced parts have been requested for return to livanova (b)(4) for further investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that a heater-cooler system 3t could not be calibrated and displayed an error message.This issue was identified by a livanova field service representative during routine maintenance.There was no patient involvement.

Manufacturer Narrative

The board and the sensor were returned for further investigation.During the evaluation the reported issue could not be confirmed or reproduced.Both parts worked according the specification.As the issue could not be reproduced or confirmed, a root cause was not identified.

Event Description

See initial.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 7546123
• MDR Text Key: 109314919
• Report Number: 9611109-2018-00991
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K052601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Model Number: 16-02-85
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1